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Dapagliflozin

Classification: A

Drug products: Forxiga, Xigduo

ATC code: A10BD15, A10BK01

Substances: dapagliflozin, dapagliflozin propanediol monohydrate

Summary

Dapagliflozin in monotherapy or in combination treatment reduces HbA1c-levels equally in men and women. Clinical studies have shown urinal infection and genital infection to be more common in women than in men on dapagliflozin treatment.
A randomized placebo-controlled study has shown that men loose more weight than women treated with dapagliflozin.
 
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.

Additional information

Pharmacokinetics and dosing

Pooled data from clinical pharmacology studies (349 men, 89 women) showed that women had a greater mean dapagliflozin AUC of 23%, even though Cmax was not increased [1]. In a population pharmacokinetic model (634 men, 619 women), mean dapagliflozin AUC at steady state was 22% higher in women than in men [1]. Despite differences described in AUC between men and women, this does not have any substantially clinically relevant impact and no dose adjustment has been considered necessary according to sex [2].

Effects

According to clinical studies done by the original manufacturer, treatment with dapagliflozin as monotherapy and in combination with metformin, glimepiride, pioglitazone, sitagliptin, or insulin reduced HbA1c at week 24 compared to control in both men and women [2]. Pooled data from several phase III studies show minimal differences in efficacy between men and women (data not shown) [1].

Adverse effects

Data from randomized placebo-controlled clinical trials [3-7] report a higher frequency of genital infections and urinary tract infections in women than men treated with dapagliflozin. Genital infections incidence rates vary from 4.3-4.5% in women and 2.0-2.1% in men. Urinary tract infections incidence rates vary from 2.8-11.9% in women and 2.0-3.5% in men. The incidence of infections was not dose-related [3-7].

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Other information

An international randomized, double-blind, placebo-controlled Phase III study (100 men, 80 women) showed a greater decrease in total body weight in men (-2.8 kg) at 24 weeks with dapagliflozin compared to women (-1.2 kg) [4].

Updated: 2019-02-26

Date of litterature search: 2014-08-29

References

  1. Kasichayanula S, Liu X, Lacreta F, Griffen SC, Boulton DW. Clinical Pharmacokinetics and Pharmacodynamics of Dapagliflozin, a Selective Inhibitor of Sodium-Glucose Co-transporter Type 2. Clin Pharmacokinet 2013 Oct 9; PubMed
  2. FARXIGA (dapagliflozin). DailyMed [www]. US National Library of Medicine. [cited 2014-08-01]. länk
  3. Bailey CJ, Iqbal N, T'joen C, List JF. Dapagliflozin monotherapy in drug-naïve patients with diabetes: a randomized-controlled trial of low-dose range. Diabetes Obes Metab. 2012;14:951-9. PubMed
  4. Bolinder J, Ljunggren Ö, Kullberg J, Johansson L, Wilding J, Langkilde AM et al. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab. 2012;97:1020-31. PubMed
  5. Wilding JP, Woo V, Soler NG, Pahor A, Sugg J, Rohwedder K et al. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann Intern Med. 2012;156:405-15. PubMed
  6. Johnsson KM, Ptaszynska A, Schmitz B, Sugg J, Parikh SJ, List JF. Urinary tract infections in patients with diabetes treated with dapagliflozin. J Diabetes Complications. 2013;27:473-8. PubMed
  7. Johnsson KM, Ptaszynska A, Schmitz B, Sugg J, Parikh SJ, List JF. Vulvovaginitis and balanitis in patients with diabetes treated with dapagliflozin. J Diabetes Complications. 2013;27:479-84. PubMed
  8. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk

Authors: Linnéa Karlsson Lind, Desirée Loikas

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson